Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Developing and maintaining software quality frameworks for clinical AI imaging and integrated workflows with an accent on SaMD compliance and regulatory standards. Focus on risk remediation, traceability reviews, and validating software used in medical device testing.

Location: Hybrid — On-site 2-3 days a week at Golden, CO office (Denver area)

Salary: $45 - $55 per hour

Company

hirify.global is a trusted leader in deep clinical AI, providing an enterprise platform to help hospitals deliver faster, more informed care through intelligent imaging.

What you will do

• Develop, implement, and maintain standards for software quality processes throughout the software life cycle.
• Ensure software project and process control documentation comply with established regulatory procedures.
• Provide Software Quality Assurance (SQA) support for R&D and production of Software as a Medical Device (SaMD).
• Review product requirements for traceability, risk remediation, and testability.
• Manage and track software problem reports and deviations through to closure.
• Support the development and validation of software utilized in SaMD testing and Jama requirements management.

Requirements

• Bachelor of Science Degree.
• 5+ years of professional experience, including a mandatory background in Software Development.
• Experience with Quality Management Systems (QMS) and SaMD development under IEC 62304.
• Prior experience using Jama Connect for requirements and traceability.
• Strong project management skills and the ability to maintain accountability to strict project deadlines.

Culture & Benefits

• Project-based engagement with a 3–6 month term.
• Full-time hours (approximately 40 hours per week).
• Opportunity to contribute to a clinically validated AI platform helping save lives globally.
• Inclusive and diverse workplace committed to equal employment opportunities.